According to the facility on (b)(6) 2023 the sample port detached from the foley catheter, requiring the facility to remove and replace the foley catheter.No additional information is available at this time.The sample has been returned for evaluation and the customer complaint has been confirmed, however, a definitive root cause cannot be determined at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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